BEUDAMED
    10,000 results · 49ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·Perclose ProStyle Suture-Mediated Closure and Repair System

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·PRO-Kinetic Energy Coronary Stent System

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG

    Stimulator, Autonomic Nerve, Implanted For Epilepsy

    FDA Pre-Market Approval
    FDA Class 3 ·SenTiva™ Generator, SenTiva Duo™ Generator

    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·Attain Ability Lead

    Heart-Valve, Mechanical

    FDA Pre-Market Approval
    FDA Class 3 ·Masters Series™ Aortic Valved Graft with Hemashield Graft Technology (CAVGJ)

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·Clareon Intraocular Lenses with the AutonoMe™ Delivery System

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL/RSR/MAGNA/MAGNA EASE/MITRAL/MAGNA MITRAL AORTIC PERICARDIAL BIOPROSTHESIS

    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

    FDA Pre-Market Approval
    FDA Class 3 ·Consulta CRT-P C4TR01; Syncra CRT-P C2TR01

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT HBSAG QUALITTATIVE/CONFIRMATORY

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·POCKET ADAPTOR KIT, ITREL 3, SYNERGY & SYNERGY VERSITREL

    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·ATTAIN PERFORMA QUADRIPOLAR LEAD

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·PRECISION SPINAL CORD STIMULATOR (SCS)SYSTEM

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·NAVISTAR & CELSIUS FAMILIES OF CATHETERS

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·AFFINITY/INTEGRITY/VICTORY/ZEPHYR FAMILY OF PACEMAKERS

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·Restylane Refyne and Restylane Defyne

    P2psa

    FDA Pre-Market Approval
    FDA Class 3 ·ACCESS P2PSA CALIBRATOR ON THE ACCESS IMMUNOASSAY ANALYZER

    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·CapSure SP Novus/CapSure SP Z/CapSure Z Novus/Vitatron Impulse II Lead

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·DEXCOM SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM